Intraoperative Aberrometry vs Conventional Intraocular Lens Calculation, a Prospective Study.

NCT ID: NCT06219252

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-03

Study Completion Date

2026-12-31

Brief Summary

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the goal of this intervention study is to compare prospectively the accuracy of the power calculation between both groups, the intraoperative aberrometry (ORA) vs barrett universal II preoperative calculation (control group) .

Researchers will compare ORA group vs control to see changes in spherical equivalent and uncorrected distance visual acuity

Detailed Description

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Studies have described a small difference between ORA (intraoperative aberrometer) and preoperative calculation with latest generation formulas ( Barrett Universal II ), the investigators intend to compare both groups prospectively, during the process randomization and blinding of the participants will be made.

The investigators will report spherical equivalent and uncorrected distance visual acuity values at 90 days of the postoperative period.

Conditions

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Intraocular Lens Implantation Cataract Humans Ocular, Refraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
None of the patients will be informed in what group they are assigned

Study Groups

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ORA group

the intraocular lens calculation in this group will be optimized by the intraoperative aberrometer (ORA)

Group Type EXPERIMENTAL

Intraoperative aberrometer

Intervention Type DEVICE

the patient intraocular lens will be optimized during the aphakic period after cataract extraction and before intraocular lens implantation, this will produce a possible change in the dioptric power of the intraocular lens

Control group

Barrett universal II will be used in the control group.

Group Type ACTIVE_COMPARATOR

Preoperative intraocular lens calculation

Intervention Type OTHER

the intraocular lens in this group will be calculated preoperatively with Barrett Universal II formula

Interventions

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Intraoperative aberrometer

the patient intraocular lens will be optimized during the aphakic period after cataract extraction and before intraocular lens implantation, this will produce a possible change in the dioptric power of the intraocular lens

Intervention Type DEVICE

Preoperative intraocular lens calculation

the intraocular lens in this group will be calculated preoperatively with Barrett Universal II formula

Intervention Type OTHER

Other Intervention Names

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ORA Barrett Universal II

Eligibility Criteria

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Inclusion Criteria

* patients with senile cataract, patients undergoing phacoemulsification, complete biometric profile, axial length calculated by interferometer.

Exclusion Criteria

* glaucoma, uncontrolled diabetic retinopathy, pseudoexfoliation syndrome, aged macular degeneration , dry eye syndrome, other ocular pathologies.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Oftalmología Fundación Conde de Valenciana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ANGEL NAVA - CASTAÑEDA, MD

Role: PRINCIPAL_INVESTIGATOR

INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA

Locations

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Instituto de oftalmología Fundación Conde de Valenciana

Mexico City, Cuauhtemoc, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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DIEGO ZAMORA - DE LA CRUZ, MD

Role: CONTACT

5554421700 ext. 3141

Facility Contacts

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Diego Zamora- de la Cruz, MD

Role: primary

5554421700 ext. 3714

Other Identifiers

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CI-005-2023

Identifier Type: -

Identifier Source: org_study_id

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